The process of drug development is generally divided into 2 stages: (1) New lead discovery (Preclinical Research), and (2) New product development (Clinical Development). Drug Safety – Pharmacovigilance Associate can work in Pharmaceuticals, Medical Device, Hospitals and research institutions, such as academic health government agencies and departments, contract research organizations/ centers. Their primary role is to identify safety and risk information, evaluate and report with regulatory authorities. The training program provides in depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Specialist including theoretical aspect of the field and exposure to variety exercises based on industry requirements.
Our Programs are delivered in 2 Different ways for convenience of student:
• Self-Paced Individual Program (SIP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions.
• Self-Paced Blended Program (SBP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 7 days Post Training Assistance program for Resume preperation.
|Category: Drug Safety||Lessons: 19 Lessons||Duration: 04 Weeks / 120 Hours||Language: English|
Recommended: A Bachelor or Master’s degree in medicine, Nursing (RN), Pharm D, Public Health, Pharmaceutical and Industrial Chemistry, Industrial Pharmacy, Industrial Chemistry.
Institutional Scholarship / Promotion is available for selected on tuition. We review your education background, certifications, and prior experiences (if applicable), to evaluate your eligibility. Qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources email@example.com to check on your eligibility. We will contact you. Qtech's objective is to provide you the right career pathway and advancement required to meet your career goals.
The Benefit Student Gains
Our objective is to help students to meet the following career pathways. Typical Drug Safety / Pharmacovigilance Associate (DSA) Job Titles the candidates can apply after this training program are :
|DRUG SAFETY MANAGER / PHARMACOVIGILANCE SPECIALIST JOB TITLES|
|Manager, Drug Safety and Pharmacovigilance||Manager, Drug Safety Science|
|Medical Operations Leader||Local Safety Manager (LSM)|
|Drug Safety Physician||Team Lead Quality & Safety|
|Therapeutic Area Lead||Safety Review Specialist – Literature team|
|Medical Reviewer||Medical Safety Manager|
Designed by industry experts for students and young professionals. The training program provides in depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Specialist including theoretical aspect of the field and exposure to variety exercises based on industry requirements.
ADDITIONAL DRUG SAFETY-PHARMACOVIGILANCE
LIST OF TOPICS:
1. Introduction to MedDRA
2. MedDRA Coding Guidelines- Part 1
3. MedDRA Coding Guidelines- Part 2
4. MedDRA Coding Guidelines- Part 3
5. MedDRA Coding Guidelines- Part 4
6. AE Causality assessments
7. ICSR Medical Causality assessment
8. Introduction to Risk Management Plan (RMP)
9. Introduction to Risk Management Plan (REMS)
10. Argus Safety End-User Training - Module 1
11. Argus Safety End-User Training - Module 2
12. Argus Safety End-User Training - Module 3
13. Argus Safety End-User Training - Module 4
14. Argus Safety End-User Training - Module 5
15. Product Quality Complaints (PTC / PQC)
16. Corrective and Preventative Actions (CAPAs)
17. Overview of Aggregate Reporting (PSUR/ PBRER)
18. Overview of Aggregate Reporting - PADER
19. Overview of Aggregate Reporting - PRAC / DSUR
5.00 average based on 3 ratings
The program gave me an in-depth understanding of the role of a DSA in Clinical Research and Pharmacovigilance department. With the practical examples and lectures from professionals I gained a clear understanding about the practical applications needed for work. Very good course work!
The best part about DSA training is presentations which clearly mention the important and key points that are helpful for building basics in the subject. I found the exercises helpful in understanding the format on how to fill the forms and analyzing the data which will be useful in real time for me.
I am a Medical Science graduate. This Certificate training helped me to understand the Job related work process better. The Drug Safety Associate training program offered at qtech is very useful for beginners, I liked it and highly recommend others. Currently I am enrolled into Internship program to meet my career goals.